Otc - Active Ingredient
Capsaicin 0.1%
Thermacare Arthritis And Nerve Pain Therapy Capsaicin Roll On Liquid
FDA Label NDC 69693-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clarion Brands Llc for the product Thermacare Arthritis And Nerve Pain Therapy Capsaicin Roll On (NDC 69693-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, inactive ingredient, otc - questions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
For temporary relief of minor aches and pains of muscles and joints associated with:
- arthritis
- muscle strains
- sprains
- bruises
- simple backache
Warnings
For external use only
Flammable
- keep away from excessive heat or open flame
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- redness is present
- irritation develops
Stop use and ask a doctor if
If pregnant or breast-feeding,
ask a health professional before use.
Otc - When Using
When using this product
- do not bandage tightly or cover treated area
- do not use with heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds, damaged, broken or irritated skin
- a transient burning sensation may occur upon application but generally disappears in several days
- if severe burning occurs, discontinue use immediately
- do not expose the area treated with product to heat or direct sunlight
- apply to affected area
- massage into painful area until thoroughly absorbed
- repeat as necessary, but no more than 3 to 4 times daily
- wash hands with soap and water after applying
Directions adults and children over 18 years of age:
Inactive Ingredient
alcohol denatured
aminomethyl propanol
carbomer
glycerin
propylene glycol
water
Otc - Questions
call 1-800-323-3383
Dosage & Administration
Capsaicin 0.1%
Topical analgesic
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Children 18 years of age or younger: ask a doctor
Package Label.Principal Display Panel
Thermacare Heat Therapy™
Penetraing CAPSAICIN soothes nerves
ARTHRITIS & NERVE PAIN THERAPY
CAPSAICIN ROLL ON
Soothes Aggravated Nerves
Deep Penetrating Warmth
Long Lasting, Fast Acting
0.1% Capsaicin
No Mess Roll On
NET WT. 2.5 oz (70.8 g)
* Please review the disclaimer below.
